Inserter guide and driver system

ABSTRACT

Disclosed herein is a guide device and a driver, which allows for the preparation of an anatomic cavity for screw fixation of an implant or spacer, including the guidance for hole preparation, and guidance for insertion of screws, and or anchors, while selecting the amount of rigidity, and selecting the amount of visibility.

BACKGROUND

In procedures such as an anterior lumbar interbody fusion (ALIF),lateral lumbar interbody fusion (XLIF), and cervical spine surgery, forexample, when a disc space has been cleared out, a metal, polymer, orbone implant/spacer is typically implanted between the two adjoiningvertebrae. After these spacers or “cages” are inserted, surgeons oftenuse metal screws, plates, and/or rods to further stabilize the spine. Toinsert the screws, a driver device having an articulating driver headmay be used to deliver the screws to the spinal column and lock them andthe spacer into place.

In many fixation procedures, particularly those around the cervicalspine, the surgeon has a very limited surgical approach and anespecially small soft tissue opening. Additionally, typical attempts atscrew hole preparation and driving of the bone screw require two hands,one to hold the guide and one to prepare the hole/drive the bone screw.During the fixation procedure, including drill guidance for holepreparation, the straight-line approach of the driver/driver structurefurther limits visibility. Accordingly, it is needed in the art to havean inserted guide and driver that are minimally invasive and provideimproved functionality while increasing visibility of both the surgicaltools and treatment area.

SUMMARY

The present disclosure provides a driver for an inserter guide system.The driver may comprise a rotatable driver shaft. The driver may alsocomprise a rod disposed within the rotatable driver shaft, as well as adriver tip coupled to the rod at a rotatable and pivotable joint. Thedriver tip may include an interface extending therefrom adapted toengage a fastener. The driver may include a housing that receives therotatable driver shaft at a distal end thereof. There may be a controlelement disposed at a proximal end of the housing. The control elementmay receive a proximal end of the rod within the housing, whereinactuation of the control element engages the proximal end of the rod,causing a distal end of the rod to frictionally engage the rotatablejoint.

Also provided herein is an inserter guide system comprising an implantholder and guide device. The implant holder and guide device maycomprise a rotatable driver shaft, a collar, and a guide. The collar maybe coupled to the end of the rotatable driver. The guide may be sizedand configured to mate with an implant. The guide may have an elongatedneck including an engagement feature for coupling with a correspondingengagement feature of the collar. The implant holder and guide devicemay also comprise housing that receives the rotatable driver shaft at adistal end thereof. In accordance with some implementations, rotation ofthe housing may result in a corresponding rotation of the collar andcoupling between the guide and collar engagement features.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofillustrative embodiments, is better understood when read in conjunctionwith the appended drawings. For the purpose of illustrating theembodiments, there are shown in the drawings example constructions ofthe embodiments; however, the embodiments are not limited to thespecific methods and instrumentalities disclosed. In the drawings:

FIG. 1 illustrates a side view of a driver device;

FIG. 2 illustrates a sectional view of the driver device of FIG. 1;

FIG. 3 illustrates a partial sectional view of the driver device of FIG.1;

FIGS. 4A-4B illustrate a perspective views of the driver tip of FIG. 1;

FIG. 5 illustrates a sectional view of the driver tip of FIGS. 4A and4B;

FIGS. 6-9 illustrate top, side, and opposing end views of an implantholder and guide device;

FIG. 10 illustrates a top sectional view of the implant holder and guidedevice of FIG. 6;

FIG. 11 illustrates a top view of an implant holder and guide device;

FIG. 12 illustrates a side sectional view of the implant holder andguide device of FIG. 11;

FIG. 13 illustrates a partial side sectional view of the implant holderand guide device of FIG. 11;

FIGS. 14 and 15 illustrate perspective views of a guide and implant;

FIG. 16 illustrates a partial perspective view of the implant holder andguide device of FIG. 6;

FIG. 17 illustrates a perspective view of the implant holder and guidedevice of FIG. 6;

FIG. 18 illustrates a side view of the guide of FIG. 16;

FIG. 19 illustrates a top perspective view of the guide of FIG. 16;

FIG. 20 illustrates a bottom view of the guide of FIG. 16;

FIG. 21 illustrates a bottom perspective view of the guide and implantof FIG. 16;

FIG. 22 illustrates a perspective side view of a rod and collar;

FIG. 23 illustrates a sectional view of the rod and collar of FIG. 22;

FIG. 24 illustrates a perspective end view of the collar of FIG. 22; and

FIGS. 25-27 illustrate a side views of example housings.

DETAILED DESCRIPTION

With references FIGS. 1-5, there is illustrated an articulating driver100 used when fixing a spinal implant between adjacent vertebra. Thearticulating driver 100 can be used to prepare an opening/hole in thevertebral body for a bone screw, pin, anchor or other fastener. Thearticulating driver 100 can also be used to drive and/or locate thefastener in the vertebral body. For example, the driver 100 can be usedas a jointed awl, a punch, a screw driver or a drill, or any otherdevice known art used for preparing an opening and inserting a fastenerinto/proximate a vertebral body.

The driver 100 can include a rotatable driver shaft 110, a rod 120disposed within the rotatable driver shaft 110, and a driver tip 130 forcoupling to a screw/fixation element (or hole creating device such as adrill tip, punch, etc.) to the distal end of the rotatable driver shaft110. The articulating driver 100 can also comprise housing 140 thatreceives the rotatable driver shaft 110 at a distal end thereof forfacilitating rotation of the driver shaft 110/driver tip 130 to drive abone screw. For example, the housing 140 can be coupled to the drivershaft 110 such that input torque received at the housing 140 is directlytransferred to the driver shaft 110 and rotates, drives or otherwiseactuates the driver tip 130, including any screw or drill componentcoupled to the driver tip 130. The housing 140 can also include acontrol element 150 disposed its proximal end. The control element 150receives a proximal end of the rod 120 within the housing 140 for fixingthe location of the rod 120 with respect to the housing and/or drivertip 130 components. The control element 150 can also be used to vary theamount of friction applied by the rod 120.

As shown in FIGS. 1 and 2, the driver 100 includes the rotatable drivershaft 110 capable of transmitting input torque to the driver tip 130.The input torque can be applied to the housing 140 or driver shaft 110by hand or use of a power tool directly or indirectly coupled to thehousing 140/driver shaft 110. The rotatable driver shaft 110, at itsproximal end, can be connected to the housing 140. It is contemplatedthat the driver shaft 110 is fixedly coupled to the housing 140 suchthat rotation/movement of the housing 140 results in a correspondingrotation/movement of the driver shaft 110. The driver shaft 110 can bepermanently and/or removably coupled to the housing 140, e.g., at aninterior surface of the housing 140. The housing 140 can also include amating sleeve 142, shown in FIG. 3, for coupling the driver shaft 110 tothe housing 140. The driver shaft 110 can be permanently and/orremovably coupled to the mating sleeve 142. The mating sleeve 142 can bepermanently and/or removably coupled to the mating housing 140. Forexample, the mating sleeve 142 can be integrally formed with the housing140 or a separate component from the housing 140. As illustrated in FIG.3, the mating sleeve 142 can be coupled to the housing 140 via threadsprovided on an interior surface of the housing 140. As will be explainedin further detail below, the control element 150 can also be coupled tothe driver shaft 110 and/or the housing 140 directly or using a matingsleeve.

At its distal end, the rotatable driver shaft 110 forms driver tip 130.Components of the driver tip 130 can articulate with respect to thedriver shaft 110 and/or rod 120 while transmitting input torque to ascrew, fastener, drill, punch, etc. coupled to the driver tip 130. Thedriver tip 130 can be integrally formed with the driver shaft 110 orconstructed as a separate component(s) coupled to the driver shaft 110.The driver tip 130 can include a ball-in-socket joint, a universaljoint, or any other type of joint/connection known in the art thatprovides rotational and pivotal control between a drive shaft and driveinterface.

As illustrated in FIGS. 4A, 4B and 5, the driver tip 130 can include aball-in-socket joint. The driver tip 130 can include adomed/spherical-shaped mating surface 131 for mating with the sphericalhead 132 of the ball-in-socket joint. The spherical head 132 can formthe proximal end of the driver tip 130. A pin 133 can extend through thespherical-shaped mating surface 131 and the spherical head 132, guidingthe pivoting movement of the head 132 with respect to the mating surface131. The pin 133 extends between opposite sides of the spherical matingsurface 131 and through a slot 134 provided in the spherical head 132.The pin 133 ensures torque/rotational force applied to the driver shaft110 is transmitted to an interface 135 provided for engaging a fixationor drill component. In particular, engagement and/or interferencebetween the pin 133, spherical mating surface 131, and the head 132/slot134 ensures that rotation of the driver tip 130/rotatable drive shaft110 results in a corresponding rotation of the spherical head132/interface 135. The pin 133 extends through a cross pin 136 providedin the spherical head 132. Rotation of the spherical head 132 on thecross pin 136 allows the spherical head 132 to pivot with respect to themating surface 131 and/or rotatable drive shaft 110. It is contemplatedthat the pin 133 and cross pin 136 can be separately and/or integrallyformed with respect to each other, the spherical head 132 and/or themating surface 131 of the rotatable driver 110.

During operation, the user can rotate/pivot the head 132 with respect tothe driver shaft 110/housing 140. Frictional engagement between the head132 and the rod 120 fixes the location/rotation of the head 132 withrespect to the driver shaft 110. Engagement between the head 132 and therod 120 allows the user to select, and fix, the angle of the rod 120with respect to the driver tip 130/interface 135. Thus, the driver tip130 of the present disclosure can be positioned stably in a multi-anglescrewing/unscrewing operation. For example, a ball-in-socket-type jointat the driver tip 130 can provide for approximately 35-55° ofangulation, and the driver 100 can maintain the driver tip 130 within auseful range of operation. It is contemplated that the driver tip 130can provide for a range of +/−45° of angulation of the interface 135 incomparison to the center axis of the rod 120. The angulation of thedriver tip 130 can exist anywhere within a three dimensional plane basedon the orientation of the spherical head 132 and mating surface 131,thereby allowing for rotation of the driver tip 130 in amultidirectional manner.

Referring to FIGS. 4A, 4B and 5, engagement of a screw or other fastenerwith the articulating driver 100/driver tip 130 will be described. It iscontemplated that similar components and features could be utilized forcoupling the driver shaft 110/driver tip 130 to a drill or otherfixation tools. At its distal end, the driver tip 130 can include aninterface 135 for engaging a screw/fixation element. The interface 135can be, for example, threaded, keyed, or otherwise disposed to interactwith a screw/fixation element. As provided in FIGS. 4A, 4B and 5, theinterface 135 can include a drive element 137 that extends/projects froman outer surface of the driver tip 130. The drive element 137/interface135 can have a size and shape that is complementary with a correspondingdrive surface included on the head of a screw or other fixation device.When torque is applied by the driver tip 130, the drive element137/interface 135 engages the head of the screw thereby to drive thescrew/fixation element.

The interface 135 can comprise a self-retaining driver. For example,interface 135 can include a sleeve 138 extending over and/or around thedrive element 137. As the drive element 137 engages the correspondingdrive surface of a screw, arms of the sleeve 138 flex around andcompress against the head of the screw. As a result, the screw isretained between the sleeve 138 and the drive element 137 when coupledwith the interface 135. Once coupled, the user can rotate the drivershaft 110 in a manner which causes the interface 135 to interactwith/drive the screw without worry that the screw will inadvertentlydisengage from the driver tip 130.

As illustrated in FIG. 2, the driver 100 includes a rod 120. The rod 120extends from the housing 140, through a central channel provided thebody portion of the rotatable driver shaft 110 to the driver tip 130.Illustrated in FIG. 5, the distal end of the rod 120 extends from theopening at the end of the channel. The end of the rod 120 can engagecertain components of the driver tip 130 to limit and/or preventrotation and pivoting movement of the driver tip 130/spherical head 132with respect to the rod 120. For example, the end of the rod 120 caninclude a friction surface 122 sized and configured to engage thespherical head 132 of the driver tip 130. In another example, the rod120 can include a mechanical engagement feature (e.g., key, recess,projection) that engages a corresponding feature on of the driver tip130/head 132. Engagement between these corresponding features limitand/or prevent rotation of the driver tip 130 with respect to the rod120 and allow the user to select the desired angle between rod 120 andthe driver tip 130.

In use, longitudinal/axial force can be applied to at proximal end ofthe rod 120 through engagement with the control element 150(alternatively referred to herein as the frictional control element). Inparticular, the control element 150 may be used to operatively controlthe amount of friction/force with which the rod 120 engages thespherical head 132 of the driver tip 130. The friction/force applied tothe spherical head 132 can vary, or can be constant based onmanipulation and design of the control element 150. For example, theamount of friction/force exerted through the control element 150 can bea constant state of friction/force. Alternatively, the rod 120 canengage the spherical head 132 with variable friction/force. For example,the amount of friction/force exerted upon the spherical head 132 by therod 120 can vary according to the amount of friction/force with whichthe user engages the control element 150.

Alternatively, various “set” positions can exist within the controlelement 150, such that a user can select a predetermined amount offriction. In one example, the control element 150 can be “locked” intoplace via engagement with the housing 140, such that the amount offriction with which the control element 150 engages the rod 120 and theamount of friction with which the rod 120 engages the driver tip130/spherical head 132, is constant when the control element 150 is inthe locked position. As illustrated in FIG. 3, the distal end of thecontrol element 150 can include an engagement feature 151 (e.g.,threads, projections, teeth, barbs) sized and configured to engage acorresponding feature 143 provided on an interior surface of the housing140. As the engagement feature 151 (e.g., threads) of the controlelement 150 engage the engagement feature 143 (e.g., threads) of thehousing 140, the rod 120 moves laterally within the driver shaft 110causing the distal end/friction surface 122 to engage/disengage thedriver tip 130/spherical head 132.

As described above, the control element 150 can be translated axially,towards/away from the distal end of the driver 100 to increase/reducethe amount of pressure applied by the rod 120 to the driver tip 130/head132. When the engagement features 151/143 are engaged, pressure appliedby the rod 120 on the head 132 remains constant and the control element150 is considered in a “locked” position. For example, when theengagement feature 151 and corresponding features 143 of the housing 140comprise threads, as rotational force is applied to the control element150 the control element 150 and rod 120 traverse the housing 140 causinga lateral force to be applied to the driver tip 130/head 132.

In another example, the control element 150 can include a spring orother feature engaged between the control element 150 and the rod 120that provides variable pressure/force to the rod 120. The user canmanipulate the control element 150 via axial movement, rotation,pushbutton, etc. to adjust the pressure/force applied to the rod 120.

As illustrated in FIG. 3, the control element 150 can include a knob152. The knob 152 can function as a dial, pushbutton, or other means toenable the user to control force/pressure on the rod 120. The knob 152can be removably or permanently coupled to the control element 150.Likewise, the knob 152 can be removably or permanently coupled to therod 120. As provided in FIG. 3, the knob 152 can be coupled to a rodengagement sleeve 123 that is fixedly or removably coupled to the rod120. The engagement features 151 for engaging the housing 140 can beprovided on the sleeve 123.

In another example, the engagement features 143 can be provided on asleeve 144 that is, in turn, fixed to/with respect to the housing 140.The sleeve 144 can extend within the housing 140 at a fixed positionsuch that the knob 152/engagement features 151/rod engagement sleeve 123move laterally with respect to both the sleeve 144 and the housing 140.

In some implementations, the various components of the driver 100 mayhave the following dimensions. The radius of curvature of the sphericalmating surface 131 may be approximately 3.6 mm and may have a depth of1.8 mm. The spherical head 132 portion may have a diameter approximately6.5 mm. The retention cap portion 139 of the driver tip 130 may have atotal height (h) of 3.0 mm (i.e., height difference between the outerradius/surface of the driver shaft 110 and the outermost radius/surfaceof the retention cap portion 139). The driver tip 130 may have a lengthof 15 mm. The interface 135 may have a depth of 3.5 mm.

Referring now to FIGS. 6-9, illustrated herein is an example implantholder and guide device 200 with a detachable guide 230. A vertebralspacer 205, bone graft, or other interbody fusion device can be coupledto the implant 232/guide 230 for insertion between adjacent vertebralbodies. Openings included in the guide 230 provide access for bone screwplacement and insertion. To improve visibly and access to the surgicalsite, various components of the guide device 200 can be removed. Forexample, the guide 230 can be detached from the implant 232 before theuser fixes the implant/spacer in place via insertion of a bone screwinto the implant 232, spacer 205, and associated vertebral body. Theshaft 210 of the holder and guide device 200 can also be detached fromthe guide 230, with the guide 230 remaining coupled to the implant 232,before insertion of the bone screw into the associated vertebral body.In another example, the shaft 210 and the collar 233 can be removed.Finally, the housing 240 can be removed from the shaft 210, leaving theshaft 210, collar 233 and guide 230 in place during the fixationprocedure.

FIG. 6 provides a top view and FIG. 7 provides a side view of theimplant holder and guide device 200 with a detachable guide 230, implant232 and spacer 205 attached. FIGS. 8 and 9 provide opposite end views ofthe implant holder and guide device 200. As illustrated in FIGS. 6 and7, the detachable guide 230 can be disposed at the distal end of theimplant holder and guide device 200. The detachable guide 230 includesan inner guide body 231 and an implant 232 (illustrated in FIG. 14). Aspacer 205, bone graft, or other interbody fusion device can be coupledto the distal end of the guide 230, at the implant 232, for insertionand placement in the vertebral disc space. A collar 233 engages thedistal end of the rotatable driver shaft 210 and provides a couplingbetween the driver shaft 210 and the main guide body 231.

Similar to the housing 140 described above with respect to the driver100 (illustrated in FIG. 3), FIGS. 6, 7, and 10 provide a housing 240for use with the implant holder and guide device 200. By manipulatingthe location of the housing 240, the user is able to locate/plate theguide 230, implant 232 and spacer 205 within the patient. The drivershaft 210 can be fixedly coupled to the housing 240 such that rotation,tension, compression, or any other movement of the housing 240 resultsin a corresponding movement of the driver shaft 210/guide 230. The guidedevice 200 can include a coupling 245, e.g., quick connect coupling, forjoining the driver shaft 210 to the housing 240. The coupling 245 caninclude an opening to receive a proximal end of the driver shaft 210.Rotational and axial movement of the driver shaft 210 can be fixed withrespect to the housing 240 at the coupling 245. As described withrespect to FIG. 22, coupling 245 can include one or more engagementfeatures for engaging corresponding key feature or recess 214 of thedriver shaft 210 to fix the rotational and/or axial movement of thedriver shaft 210. The coupling 245 can be fixedly or removably coupledto the housing 240. For example, as illustrated in FIG. 10, the coupling245 can be threaded into the housing 240.

FIG. 10 provides a cross-sectional view of the guide 230. The drivershaft 210 interacts with the detachable guide 230 at the distal end ofthe implant holder and guide device 200. For example, the driver shaft210 can be permanently or removably coupled to the collar 233 which is,in turn, coupled to the guide body 231. As illustrated in FIG. 10, thedriver shaft 210 can threadably engage a threaded interface 234 providedon the collar 233. The driver shaft 210 can be detached from the guide230 during the implantation procedure to allow for increased visibilityand access.

The guide 230/guide body 231 can be threadably coupled to the collar233. For example, the guide body 231 can include a threaded interface247 provided on the neck 243 of the guide body 231 for engaging thethreaded interface 234 provided on the collar 233. The guide body 231can be formed to include spaced apart opposing halves (231 a, 231 b)joined together at their proximal end (see e.g., FIG. 18). Duringoperation, as the driver shaft 210 is rotated (via rotation of housing240) torque is transmitted to the collar 233 causing the collar 233 toengage the guide 230. As the collar 233 is translated towards the distalend of the holder and guide device 200 (e.g., by rotation of the collar233 and engagement with the guide body 231), opposing halves (231 a, 231b) of the guide body 231 move together. In moving opposing halves of theguide body 231 together/towards each other, the guide body 231compresses against the associated implant 232 and secures the implant232 to the guide 230. Likewise, the guide 230 can be removed from theimplant 232 by disengagement between the collar 233 and the inner guidebody 231 and the corresponding movement/separation of the guide bodyhalves (231 a, 231 b).

FIG. 11 provides a top view of an example implant holder and guidedevice 200 and detachable guide 230 without either an implant or spacerattached. FIG. 12 provides a side cross-section view of the implantholder and guide device 200 of FIG. 11. The implant holder and guidedevice 200 can include a housing and shaft structure similar to thedriver 100 described above. For example, the implant holder and guidedevice 200 can include a rotatable driver shaft 210, a rod 220 disposedwithin the rotatable driver shaft 210, housing 240 that receives thedriver shaft 210, and a control element 250.

As illustrated in FIG. 13, the driver shaft 210 can be threadablycoupled to the collar 233 at a threaded interface 234 provided on thecollar 233. The rod 220 extends within the driver shaft 210 and can bereceived within a recess provided in the proximal end of the guide 230.The driver shaft 210 and rod 220 can be detached from the guide 230during the implantation procedure to allow for increased visibility andaccess.

The guide 230/guide body 231 can also be threadably or otherwise coupledto the collar 233. The guide body 231 can include spaced apart opposinghalves (231 a, 231 b) joined together at their proximal end. As thedriver shaft 210 is rotated (via rotation of housing 240) torque istransmitted to the collar 233 causing the collar 233 to engage the guide230. As the collar 233 is rotated and translated towards the distal endof the holder and guide device 200, an angled cam surface of the collar233 engages a corresponding angled cam surface of the opposing guidebody halves 231 a, 231 b. As a result, the opposing halves 231 a, 231 bof the guide body 231 move together and the guide body 231 compressesagainst the associated implant 232.

Referring FIGS. 14 and 15, the detachable guide 230 can include animplant 232. The implant 232 can be removably or permanently coupled toa spacer 205, bone graft, or other interbody fusion device. To increasestability of the spacer, the implant 232 remains coupled to the spacerfollowing insertion and removal of the guide body 231 from the patient.That is, the implant 232 can remain coupled to the spacer/bone graft andpermanently remain in the patient as part of the implant.

The implant 232 can include arms 235 extending from the distal endand/or sides of the implant 232. The arms 235 can be expanded/flexed ina direction away from the centerline of the holder and guide device 200and around a spacer. Pressure applied by the arms 235 secure the spacerto the implant 232. The arms 235 can include engagement features (e.g.,projecting teeth) that engage the implant. The implant 232 can includestops 236 extending from a side surface of the implant 232 to controlinsertion of the spacer/implant 232 into the vertebral disc space. Stops236 can be sized and configured to interfere/contact various anatomicalstructure to control the depth and location of spacer/implant 232placement. For example, stops 236 can be used to prevent insertion ofthe inner guide body 231 into the disc space. The coupling between thespacer, implant 232 and inner guide body 231 secure the guide 230 inplace when it is detached from shaft portions of the implant holder andguide device 200.

As illustrated in FIGS. 14 and 15, the inner guide body 231 can includea number of openings 237. The openings 237 provide access for and guidebone screw placement and insertion into the implant 232/spacer/vertebralbody. An operator may couple the spacer to the vertebral body byinserting the screw into an appropriate one of the openings 237. Thescrew will pass through the opening 237 and out of the guide 230. Thescrew may engage the implant 232 and secure the implant 232 in thepatient and permanently couple the implant 232 to the spacer.

In some examples, as illustrated in FIGS. 14 and 16, the implant holderand guide device 200 can include blocks 341 extending over the guidebody 231. Opposing blocks 341 can be provided to fit over the opposinghalves 231 a, 231 b of the guide body 231. The blocks 341 can extendbetween the shoulder 242 (see FIG. 18) extending from the neck 243 ofthe opposing halves 231 a, 231 b to the bottom surface 244 of the guidebody 231. All or a portion of the shoulder 242 may be received withinthe blocks 341.

FIGS. 16 and 17 provide perspective views of the distal end of theexample implant holder and guide device 200 of FIG. 6. As illustrated inFIG. 16, the guide body 231 can include sleeves 238 projecting fromaround the openings 237. These sleeves 238 provide guidance and supportfor a screw or other instrument inserted into the opening 237. Likewise,projections 239 extending from the bottom surface of the guide body 231are sized and configured to engage a corresponding opening in theimplant 232. As illustrated in the guide 230 depicted in FIGS. 18-20,the projections 239 can include a conical-shaped end to facilitateadvancement into openings provided in the implant 232. The projections239 can extend at an angle from the bottom surface 244 of the guide 230such that as the opposing halves 231 a, 231 b of the guide body 231 arebrought together, an implant 232 coupled to the guide 230 at projections239 is drawn up the projections 239 toward/in contact with the bottomsurface 244 of the guide 230. The projections 239 can also include acentral opening extending therethrough. The central opening can provideaccess for awl, punch, drill, driver, or any other device known art usedfor preparing an opening and/or guiding and inserting a fastener throughthe guide 230 and into/proximate a vertebral body.

FIG. 21 illustrates a bottom perspective view of the implant holder andguide device of FIG. 16 with an implant 232 attached. As describedabove, the projections 239 extend from the bottom surface 244 of theguide body 231 are sized and configured to engage a correspondingopening 246 in the implant 232. Likewise, as the implant 232 is intendedto remain in the patient and permanently coupled to the spacer, the bonescrew may engage threads 248 (or other fastener feature) provided in thecorresponding opening 246 of the implant 232. The implant 232 includesarms 235 for coupling to an implant. The arms 235 can includeprojects/recesses for engaging and retaining the implant on the implant232. Likewise, the arms 235 can include one or more grooves on the outersurface of the arm 235 for engaging the spacer.

FIG. 22 illustrates a perspective side view of a driver shaft 210 andcollar 233. The collar 233 may be fixedly or removably coupled to thedriver shaft 210. Likewise, the collar 233 may have a fixed positionwith respect to the driver shaft 210 or the collar 233 may be move(rotate, translate longitudinally) with respect to the driver shaft 210.As illustrated in FIG. 22, the proximal end of the driver shaft 210 caninclude a key feature 312 sized and configured to couple with thecorresponding housing and/or control element. The key 312 can ensurerotational movement of the driver shaft 210 corresponds to similarmovement of the housing/control element. Likewise, the proximal end ofthe driver shaft 210 can include a recess 314 sized and configured toengage a corresponding engagement feature of the housing. Couplingbetween the recess 314 and the housing can be used to fixlongitudinal/axial movement of the driver shaft 210 with respect to thehousing.

FIG. 24 provides a perspective view of the distal end of the collar 233and driver shaft 210. As described above, the collar 233 can include athreaded interface 234 for engaging the rod and/or guide. For example,the threaded interface 234 can engage a corresponding threaded interface247 provided on the guide 230. As illustrated in FIG. 23, the drivershaft 210 and collar 233 can have unitary construction. Accordingly,rotational movement of the driver shaft 210 results in correspondingrotational movement of the collar 233. As a result, the collar 233 canengage/disengage the guide 230 and can draw the opposing halves 231 a,231 b of the guide body 231 together/apart. The threaded interface 234can be recessed within the collar 233. The opening 251 at the distal endof the collar 233 can be sized to accommodate the neck 243 of the guidebody 231, including all or a portion of the shoulder 242. The opening251 can also be sized such that all, or a portion of, the shoulder 242is prevented from extending within the opening. For example, asillustrated in FIGS. 10 and 12, the opening 251 can include acam/tapered surface 252 corresponding to a taper of the shoulder 242 orother portion of the guide body 231. Interaction/contact between thetapered surface 252 and the shoulder 242 can cause the opposing halves231 a, 231 b of the guide body 231 to draw together/move apart.

As described above, the driver 100 and implant holder/guide device 200,300 include housings 140, 240 at their proximal end. The housings 140,240 can include a control element 150 for controlling driver tip130/guide 230 functionality. While the control element 150 has beendepicted as extending from the proximal end of the housing 140, 240 itis contemplated that the control element 150, may have different shape,location and interaction with the housing 140, 240. For example, thecontrol element 150 may be disposed laterally along housing 140, 240, orat the distal end of housing 140, 240. Actuation of the control element150 can engage the proximal end of the rod 120, 220, moving the drivertip 130/inner guide body 231 laterally with respect to the shaft 110,210.

Various examples of control elements and their relationship to thehousing are shown in FIGS. 25-27. FIGS. 25-27 provide a housing 340similar in size and function to the housings 140, 240. The housing 340can be coupled to the proximal end of the driver and the implant holderand guide device in any of the disclosed examples.

FIG. 25 shows an example housing 340 having a control element 350including a dial 351 and a lever lock 352 mechanism. In an examplehousing 340, the dial 351 can be rotatably disposed along the distal endof the housing 340 and the lever lock 352 can be provided proximal thedial 351. The dial 351 and lever lock 352 allow the user to set thedesired angle of the driver tip/implant holder/guide device. Forexample, the user can move the housing 340 to the desired angle(manually) and set the desired tension/drag between the driver tip/guideand the driver shaft/rod using dial 351. The dial 351 can also be usedto lock the angle of the driver tip/implant holder/guide device withrespect to the driver shaft/rod. The housing 340 can include a leverlock 352 used to release the housing 340 from the driver or implantholder/guide device 200 (e.g., release the housing from the drivershaft/rod).

FIG. 26 shows an optional housing 340 having a control element 350 thatincludes a rotatable knob 353. The desired angle of the device can beset by manually moving the housing 340 with respect to the drivertip/guide. The angle is held using the control element 350 mechanism andcontrolled by rotation of the knob 353. For example, tension between therod and the driver tip/guide is controlled by rotation of the knob 353and can be released by rotation of the knob 353 in the oppositedirection. Optionally, the amount of tension can be set/fixed by alocking mechanism used in conjunction with the knob 353.

FIG. 27 shows an optional housing 340 having a control element 350including a push button 354. The desired angle can be set by manuallymoving the housing 340 with respect to the driver tip/guide. The pushbutton 354 can be compressed/released to set a pre-defined tensionbetween the rod and the driver tip/guide. For example, the push button354 can control multiple tension settings, wherein each depression ofthe push button 354 increases tension, and final push of the push button354 completely releases tension.

Disclosed herein are methods for using the implant holder and guidedevice 200 and the driver 100, both individually and/or together. Afterthe surgical site is prepared and disc material removed, the implantholder and guide device 200 can be used to insert the implant/spacer inthe disc space. As outlined above, the detachable guide 230 is coupledto the rotatable driver shaft 210. For example, the proximal end/neck243 of the guide 230 can be brought into contact with the collar 233.Rotation of the housing 240 causes the threaded interface 234 of thecollar 233 to engage the corresponding interface 247 on the guide 230.

The implant 232 can then be coupled to the guide 230 (it is alsocontemplated that the implant 232 can be coupled to the guide 230 beforethe guide 230 is coupled to the driver shaft 210). As described above,projections 239 extending from the guide 230 are sized and configured toengage a corresponding opening in the implant 232. The implant 232 issecured to the guide 230 by further engagement between the driver shaft210 and the guide 230/collar 233. As the driver shaft 210 engages theguide 230/collar 233, opposing halves of the guide body 231 a, 231 bmove together/towards each other. As a result, the projection 239 and/orguide 230 compresses against the associated implant 232 and secures theimplant 232 to the guide 230.

Just as the implant 232 can be coupled to the guide 230 before/aftercoupling with the driver shaft 210, likewise, a spacer/bone graft can becoupled to the implant 232 before or after the implant 232 is coupled tothe guide 230. As illustrated in FIG. 14, for example, the implant 232includes arms 235 that can expand/flex around the spacer/bone graft.Pressure applied by the arms 235 secures the spacer to the implant 232and guide 230. Likewise, engagement features (teeth, grooves, barbs,etc.) included on the arms 235 can be included to secure the spacer tothe arms 235.

With the spacer coupled to the implant holder and guide device 200, thespacer can be inserted into the disc space. Once the implant is fixed ina desired location within the patient, the detachable guide 230 can beremoved from the implant 232. Removing the guide 230 from the patient,improves visibly and access to the surgical site for the fixationportion of the procedure. The guide 230 is removed from the implant 232by manipulating/rotating the housing 240 (according to the variousexamples outlined herein). In one example, the detachable guide 230 isthreadably engaged with the collar 233, and can be released byunscrewing the guide 230/collar 233 and allowing the opposing halves 231a, 231 b of the guide 230 to release from the implant 232. It is alsocontemplated that the guide 230 (with or without the collar 233) willremain attached to the implant 232 during the fixation procedure. Forexample, the shaft 210 and housing 240 can be detached from the guide230/collar 233 to improve visibility and access to the surgical site. Itis further contemplated, that the guide 230, collar 233 and driver shaft210 will remain coupled to the implant 232, only removing the housing240, prior to the fixation procedure.

Once the user has removed the desired components from the implant holderand guide device 200 (e.g., only housing 240; housing 240 and drivershaft 210; housing 240, driver shaft 210 and collar 233; or housing 240,driver shaft 210, collar 233 and guide 230), the driver 100 can be usedto place a screw or other fixation device into the spacer/implant 232,or directly into bone. Optionally, a screw is attached to the driver 100through the interface 135 of the driver tip 130. As outlined above, theangle of the driver tip 130 with respect to the driver shaft 110 can beadjusted to accommodate the location of the implant and patient anatomy.For example, the user can (manually) adjust the angle of the driver tip130 before coupling the interface 135/screw with the implant 232/guide230. In another example, the user can insert the driver 100 into thesurgical opening, couple the interface 135/screw with the implant232/guide 230, and adjust the angle of the driver tip 130 by adjustingthe angle of the driver shaft 110. Once the desired angle is achieved,the user can release the rod 120 and cause the rod 120 to engage therotatable joint of the driver tip 130 thereby “locking” the angle of thedriver tip 130 and preventing any further movement/change in anglebetween the driver tip 130 and the driver shaft 110. For example, asdescribed above, where the rotatable joint comprises a ball-in-socketjoint, the friction surface 122 of the rod 120 can engage the sphericalhead 132 of the driver tip 130. Frictional engagement between thefriction surface 122 and the head 132 prevents any movement/change inangle between the driver tip 130 and the rod 120/driver shaft 110.

The “locked” screw/driver tip 130 is then inserted into the patienttowards the guide 230. Fixing the angle of the driver tip 130 prior toinsertion into the patient allows the user to identify a beneficialapproach angle and minimize incision size and tissue trauma. Once the“locked” screw/driver tip 130 is positioned within the guide 230, thefriction surface 122 of the rod 120 can be released from the head 132,i.e., the driver tip 130 can be “unlocked.” The housing 140/rotatabledriver shaft 110 can then be rotated to cause the screw to engage theimplant 232/guide 230 and fix the implant 232/guide 230 to the spacer205 and corresponding vertebral bodies. The guide 230 can be used toguide the screw into the proper location within the patient. Once thescrew or other fixation device is properly affixed, the driver 100 canbe removed from the patient.

As outlined above, the guide 230 can remain in the patient during thefixation procedure. Once the driver 100 has been used to fix thespacer/implant 232 in the disc space, the guide 230 can be removed fromthe patient by reattaching the shaft 210 of the implant holder and guidedevice 200 to the guide 230. Once the guide 230 is reattached to theimplant holder and guide device 200, the user can release the guide 230from the implant 232 as described above and remove the guide 230 fromthe patient by lifting the guide 230 through the surgical opening.

As outlined above, it is also contemplated that the driver 100 can actas a drill to prepare an opening for a corresponding bone screw. Theangle of the driver tip 130/drill can be adjusted as described abovewith respect to insertion of a bone screw.

The various components above may be made from PEEK, stainless steel,titanium, titanium alloy, ceramic, polyethylene, or any metallic orpolymetric material. The various components may also include a TiNcoating to limit wear and galling.

Although the subject matter has been described in language specific tostructural features and/or methodological acts, it is to be understoodthat the subject matter defined in the appended claims is notnecessarily limited to the specific features or acts described above.Rather, the specific features and acts described above are disclosed asexample forms of implementing the claims.

What is claimed:
 1. A driver comprising: a rotatable driver shaft; a roddisposed within the rotatable driver shaft; a driver tip at a distal endof the rotatable driver shaft, the driver tip coupled to the rotatabledriver shaft at a rotatable joint; a housing that receives the rotatabledriver shaft at a distal end thereof; and a control element disposed ata proximal end of the housing, the control element receiving a proximalend of the rod, wherein actuation of the control element engages theproximal end of the rod, causing a distal end of the rod to frictionallyengage the rotatable joint.
 2. The driver of claim 1, wherein therotatable joint comprises a spherical head and a mating surface having adomed surface to mate with the spherical head, wherein the sphericalhead includes an interface extending therefrom adapted to engage afastener.
 3. The driver of claim 2, wherein the rod is adapted tofrictionally engage the spherical head, wherein the an angle of thedriver tip relative to a longitudinal axis of the rotatable driver shaftcan be adjusted to a present angle and held at the preset angle throughthe frictional engagement of between the spherical head and the rod. 4.The driver of claim 1, wherein a axial force is applied to the proximalend of the rod through engagement between the control element with therod.
 5. The driver of claim 1, wherein the housing is coupled to therotatable driver shaft such that movement of the housing causescorresponding movement of the driver shaft and a resulting pivotingmovement of the rotatable joint, thereby allowing the angle of thedriver tip to change with respect to the driver shaft.
 6. The driver ofclaim 1, wherein engagement between the rod and the control elementfixes a position of the rod within the housing.
 7. The driver of claim1, wherein the rod is spring loaded within the housing.
 8. The driver ofclaim 1, wherein the driver tip includes an interface extendingtherefrom adapted to engage a fastener, wherein the angle of theinterface with respect to the rod can vary by up to about 180°.
 9. Thedriver of claim 1, wherein the driver tip includes an interfaceextending therefrom adapted to engage a fastener, wherein the angle ofthe interface with respect to the rod can vary by about 45°.
 10. Animplant holder and guide device comprising: a rotatable driver shaft; acollar coupled to the distal end of the rotatable driver shaft; a guidesized and configured to mate with an implant, the guide having anelongated neck including an engagement feature for coupling with acorresponding engagement feature of the collar; a housing that receivesthe rotatable driver shaft at a distal end thereof; wherein rotation ofthe housing results in a corresponding rotation of the collar andcoupling between the guide and collar engagement features.
 11. Thedevice of claim 10, wherein the guide comprises a first guide body andan opposing second guide body, the first and second guide bodies spacedapart from each other and coupled at a proximal end of the neck, whereina gap between the first and second guide body can be reduced bycompressing the first and second guide bodies towards each other. 12.The device of claim 11, wherein the first and second guide bodies arecompressed towards each other by engagement between the collar and theguide.
 13. The device of claim 11, wherein the engagement feature of theguide threadedly engages the corresponding engagement feature of thecollar, wherein the first and second guide bodies are coupled at theneck at a location corresponding to the engagement feature.
 14. Thedevice of claim 13, wherein the first and second guide bodies are biasedin a spaced apart position.
 15. The device of claim 10, wherein theguide comprises a through hole extending transverse to a longitudinalaxis of the guide, the through hole sized and configured to accommodateat least one of bone screw, pin, anchor, drill, punch, awl, and guide.16. The device of claim 15, wherein the guide includes an annular sleeveextending from the through hole in a direction away from the guide. 17.The device of claim 11, further including an implant coupled to theguide for engaging an interbody fusion device.
 18. The device of claim17, guide includes a projection extending from a bottom surface sizedand configured to engage a corresponding opening provided on a topsurface of the implant, wherein compression of the first and secondguide bodies secures the implant to the guide by compressing theprojection against the opening of the implant.
 19. The device of claim18, wherein the guide comprises a through hole extending transverse to alongitudinal axis of the guide, the through hole sized and configured toaccommodate at least one of bone screw, pin, anchor, drill, punch, awl,and guide wire, wherein the through hole extends through the projection.20. The device of claim 17, further including: an interbody fusiondevice coupled to the implant, wherein the interbody fusion devisecomprises at least one of a spacer and a bone graft.